ATN 166: CHOOSE

Study Summary:

Pre-exposure prophylaxis (HIV PrEP) is a pill or a shot that can prevent HIV infection. Doxycycline, an antibiotic, can be taken after sex by men and transgender women to prevent sexually transmitted infections (STIs) – this approach is called DoxyPEP. The CHOOSE Study (Combatting HIV Or Other STIs Early) is a study to help young gay, bisexual, and other men who have sex with men (YGBMSM) to decide if HIV PrEP and DoxyPEP are good options for them, and to help them to take these highly effective prevention tools.

What is the study trying to discover?

The goal of CHOOSE (ATN 166) is to determine whether a package of 3 mobile health tools can help YGBMSM to choose which type of PrEP may work best for them, and to support them in taking these HIV PrEP medications. The 3 tools are:

1. MyPrEP website: helps YGBMSM choose the type of PrEP that may work best for them
2. PrEPsmart: an app that helps people taking PrEP pills to know when their next dose is due, and to give them feedback about their level of protection from HIV
3. PrEPmate: a two-way communication platform, using SMS texting, to check in with YGBMSM about whether they are having any difficulties taking HIV PrEP or DoxyPEP and to provide them with counseling.

This study will also offer DoxyPEP to all YGBMSM in the study and determine who is interested in taking it and whether they take it as recommended.

Why is this study important?

Rates of new HIV and sexually transmitted infections (STIs) are high among young gay, bisexual, and other men who have sex with men (YGBMSM). HIV PrEP is highly effective in preventing HIV infection, and Doxy-PEP is highly effective in preventing STIs. There are now 4 choices of HIV PrEP for YGBMSM to choose from (including pills taken every day or before/after sex, and an injectable medication taken every 2 months), and to make a choice that works best for them, YGBMSM may need more information about these different forms of HIV PrEP. Furthermore, people may need support in knowing when to take their next PrEP pill or come in for their next PrEP injection, and may want to be able to talk with a provider about any difficulties they are having using either HIV PrEP or Doxy-PEP. This combination of mobile health tools may help people be successful in taking HIV PrEP and Doxy-PEP.

Who is this study for?   

This study will initially enroll 24-32 English- or Spanish-speaking YGBMSM to help us finalize the 3 HIV PrEP support tools. Then, 20 YGBMSM will test the tools for 3 months. Finally, 200 YGBMSM will participate in an 18-month study to see whether these tools will help people take HIV PrEP, and to understand who uses Doxy-PEP, whether they are able to take it as recommended, and how well it works.

What happens during the study?

In the main part of the study, 100 YGBMSM will be randomly chosen to get the 3 mobile health tools immediately, while the other 100 participants will get the 3 mobile health tools after 9 months in the study. All participants will have free access to the different HIV PrEP options and Doxy-PEP, and will receive counseling about these different prevention tools. Participants will be seen every 2-3 months for visits to receive HIV PrEP and Doxy-PEP, answer study questions, and undergo HIV and STI testing.